NCT01567267

Brief Summary

The purpose of this study is to identify the effect of a short term educational intervention for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good Scientific Practice (GSP) to high-school biology students.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

8.6 years

First QC Date

March 14, 2012

Last Update Submit

March 1, 2017

Conditions

Keywords

Evidence-based MedicineGood Scientific PracticeProblem-based LearningCritical health literacyEducational intervention

Outcome Measures

Primary Outcomes (1)

  • Difference in knowledge about EbM/GSP

    Difference in knowledge about EbM/GSP measured by alternating standardized, pre-validated, single-best/short-answer questionnaires consisting of 20 questions each

    Before (day1), during (day 2) and after (day 4) intervention

Secondary Outcomes (4)

  • Difference in skills about critically appraising scientific literature

    Before (day 1), during (day 2) and after (day 4) intervention

  • Skills in teaching principles of EbM and GSP to high school students in intervention group

    After educational intervention (day 5)

  • Overall acceptance of educational intervention study participants

    During (day 2) and after intervention (day 4)

  • Overall acceptance of study lessons for biology high-school students

    After study lessons (day 5)

Study Arms (2)

Experimental educational intervention

EXPERIMENTAL

Experimental educational intervention

Behavioral: Experimental educational intervention

Standard educational intervention

ACTIVE COMPARATOR

Standard educational intervention

Behavioral: Standard educational intervention

Interventions

Educational intervention consisting of a 4-day-course in Evidence-based Medicine and Good Scientific Practice combined with the method of Problem-based Learning.

Experimental educational intervention

Educational intervention on the didactics of biology (4-day-course) not containing elements of Evidence-based Medicine, Good Scientific Practice or Problem-based learning.

Standard educational intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • students becoming biology teachers at participating university during enrollment period

You may not qualify if:

  • refusal to participate in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Siegen, Section of biology and und their didactics

Siegen, 57068, Germany

Location

Related Publications (1)

  • Matic-Strametz M, Strametz R, Bohrt K, Ochsendorf F, Weberschock T. [Students in Training to Become Biology Teachers - a controlled phase II trial (NCT01567267)]. Z Evid Fortbild Qual Gesundhwes. 2013;107(1):53-61. doi: 10.1016/j.zefq.2012.11.017. Epub 2012 Dec 7. German.

MeSH Terms

Conditions

Behavior

Study Officials

  • Reinhard Strametz, MD

    EbM Working Group, Institute for General Practice, Faculty of Medicine, Goethe University, Frankfurt/Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, EbM Working Group, Institute for General Practice, Faculty of Medicine

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 30, 2012

Study Start

February 1, 2010

Primary Completion

September 1, 2018

Study Completion

May 1, 2019

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations